Z-2528-2026Class II

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number...

Name: Z-2528-2026 Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number...
Creator: Zimmer, Inc.
Published: 2026-05-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2026-05-20 / Open, Classified

FDA source

Zimmer, Inc. began a recall of Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241 on 2026-05-20. FDA classified it as Class II and gives the reason as "Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2528-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-20
Posted: 2026-06-23
Recalling firm: Zimmer GmbH
Product: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE RECALL CORRECTION notification letter dated 5/26/26 was sent to customers. Distributor Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement for each return and send to [email protected]. 3. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons who are current users of the affected products that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-348-2759 between 8:00 a.m. and 5:00 p.m. Eastern, Monday through Friday. Alternatively, your questions may be emailed to [email protected]. Risk Manager Responsibilities: 1. Review this correction notice and ensure that affected personnel are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 3. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-348-2759 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, y
Quantity in commerce: 435 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2528-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2527-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23
Z-2528-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23
Z-2529-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23
Z-2530-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23
Z-2531-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23

Product code PHX

K241043Class IIAugment Off-Axis Instrument SystemFix Surgical / cleared 2024-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)